Perspectives in clinical research
-
Paracetamol; a cyclooxygenase inhibitor; acts through the central nervous system as well as serotoninergic system as a nonopioid analgesic. A prospective, double-blinded, and randomized-controlled study was carried out to compare the efficacy of preoperative 1g intravenous (iv) paracetamol with placebo in providing postoperative analgesia in head-neck cancer surgery. ⋯ The study demonstrates the effectiveness of ivparacetamol as preemptive analgesic in the postoperative pain control after head-neck cancer surgery and earlier discharge from hospital.
-
The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. ⋯ The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance activities conducted during clinical trials; and, hence the functioning of the ECs to safeguard the safety of patients during clinical trials remains questionable. There is a definite need for immediate intervention in the form of mandatory training hours for EC members about pharmacovigilance activities and reporting timelines to ensure clinical trial subject safety in the long run.
-
Ethics committee (EC) organization and standardization is an important aspect of clinical research. There is a healthy trend worldwide to register and/or accredit research ECs reviewing clinical research. This article tries to focus on the existing model of ECs worldwide, as against the Indian backdrop. ⋯ The challenges faced during the ethical review, especially in case of multicenter trials, have been identified. A solution has been suggested to overcome these challenges, and to ensure the overall smooth functioning of clinical trials. The article proposes the development of national and regional central ECs to counter the current drawbacks in the ethical review mechanisms in India.
-
Intravenous patient-controlled analgesia (PCA) with morphine is commonly used for post-operative pain after major surgery. Ketamine has analgesic property at lower doses, and in combination with opioids it could have synergistic effect. The aim of this study is to determine effects of the addition of ketamine to morphine for PCA after orthopedic surgery. ⋯ After orthopedic surgery, the addition of ketamine to morphine for intravenous PCA was superior to Intravenous PCA opioid alone. The combination induces a significant reduction in pain score and cumulative morphine consumption.
-
Self medication is an important concern for health authorities at global level. This study was aimed to find the prevalence of self medication for allopathic drugs and associated factors among households of urban community. This study was also aimed at assessing the attitude of respondents who had experienced self-medication. ⋯ Self-medication is an important health issue in this area. Health education of the public and regulation of pharmacies may help in limiting the self-medication practices.